Kidney CalculiNCT06684756
Comparison of Vacuum-Assisted and Conventional Ureteral Access Sheath in Retrograde Intrarenal Surgery
A study testing Retrograde intrarenal surgery in people with Kidney Calculi and Kidney Stones, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the efficacy and safety, the ratio of stone-free rates, and complications of two types of access sheaths used in retrograde intrarenal surgery to treat upper urothelial stones. The access sheath types are those with vacuum aspiration and the conventional ones. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Kidney Calculi, Kidney Stones
- What is being tested?
- Retrograde intrarenal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Patients below 85 years of age
- Patients with 11-13 FR conventional/vacuum-assisted ureteral access sheath (UAS) during retrograde intrarenal surgery
Who cannot join
- Patients with non-sterile preoperative urine culture
- Patients with renal anatomic anomalies
- Patients with a solitary (single) kidney
- Patients with insufficient data
- Patients under the age of 18, above the age of 85
- Patients without an UAS during RIRS
- Patients without 11-13Fr UAS during RIRS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tekirdag Namık Kemal University
Tekirdağ, Turkey
About this study
Official title: The Comparison of the Efficacy and Safety of Vacuum-Assisted and Conventional Ureteral Access Sheath in Retrograde Intrarenal Surgery: A Randomized Controlled Prospective Multicenter Study
This study aims to compare the efficacy and safety, the ratio of stone-free rates, and complications of two types of access sheaths used in retrograde intrarenal surgery to treat upper urothelial stones. The access sheath types are those with vacuum aspiration and the conventional ones.
Read the detailed description
The use of ureteral access sheath (UAS) during Retrograde Intrarenal Surgery (RIRS) has been proven effective and reliable in recent years, and publications indicate that it reduces stone-free rates (SFR). Their use is also recommended in the European Urology Guidelines because it improves image quality, reduces intrarenal pressure, and shortens the operation time. For this reason, it has been routinely used in many RIRS cases. In cases where non-vacuum-assisted UAS is used, fragments during stone fragmentation remain in the kidney, and since it is not possible to remove the stones simultaneously, the image may be distorted, and the operation duration may be prolonged. All these may pave the way for postoperative infectious complications. In addition to non-vacuum-assisted UAS, new UASs with flexible ends and vacuum-assisted aspiration have been introduced in the last few years (ClearPetra). Thanks to the aspiration connected to the system, stone fragments can be removed from the body with negative pressure during stone fragmentation. Continuous circulation prevents bleeding during fragmentation and blurring of the visual field due to stone fragments. In addition, since the stone fragments pass through the edges of the sheath without breaking and are removed, a perfect field of view can be provided. Unlike the classical UAS, the tip is flexible, allowing for the safe removal of lower pole stones. Many studies in the literature compare the success and complications of RIRS in cases where conventional UAS was used and not used. In addition, there are publications related to using the newly introduced aspiration access sheath in percutaneous nephrolithotomy. In retrospective publications on using this UAS in RIRS, it has been shown that stone-free rates, operation time, hemoglobin loss, and postoperative infective complications are more successful on the 1st and 30th postoperative days compared to cases where non-vacuum-assisted UAS was used. There is no randomized controlled prospective publication on this subject. This study aims to compare the complications and stone-free rates of RIRS cases where non-vacuum-assisted UAS and new vacuum-assisted UAS were used.
- Conditions
- Kidney Calculi, Kidney Stones
- Being tested
- Retrograde intrarenal surgery
- Keywords
- kidney stone, retrograde intrarenal surgery, ureteral access sheath, vacuum assisted
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde intrarenal surgeryProcedure or surgery
Flexible optic devices and lasers fragment kidney stones during this operation. In this surgery, an ureteral access sheath is recommended to be used.
| Study group | Role | What they receive |
|---|---|---|
| Patients with conventional UAS being used in their RIRS operations | Active comparator | The patient population will be selected from cases determined by randomization and used with UAS without an aspiration (conventional) during RIRS. Receives: Procedure: Retrograde intrarenal surgery |
| Patients with vacuum assisted UAS being used in their RIRS operations | Experimental | The patient population will be selected from cases determined by randomization and used with UAS with an aspiration and flexible tip, different from the conventional one during RIRS. Receives: Procedure: Retrograde intrarenal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rates
Presence/absence of residual fragments in postoperative imaging, if any, diameter of longest axis in mm.
Measured: Stone-free status will be checked by performing a non-contrast abdominal CT scan 1 month after the operation.
Secondary outcomes (1)
Complication rates
Peroperative and postoperative complication rates, whether UAS related or not
Measured: Peroperative complication rates will be determined during the operation, and postoperative complications will be re-evaluated during hospitalization before discharge or in the first month after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Fatih Şahin, Namik Kemal University
- Investigators
- Cenk M. Yazici, Professor, Study director, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684756
- Sponsor's protocol ID
- 2024.288.10.16
- Status last verified
- Jul 2026
- First submitted
- 8 Nov 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang D, Xu Y, Liu Z, Liang J, Lai D, Guan W, Xu G. Using vacuum-assisted ureteral access sheath in the treatment of complex steinstrasse. Urolithiasis. 2023 Jun 22;51(1):89. doi: 10.1007/s00240-023-01462-2.
PubMed 37347309Zhang Z, Xie T, Li F, Wang X, Liu F, Jiang B, Zou X, Zhang G, Yuan Y, Xiao R, Wu G, Qian B. Comparison of traditional and novel tip-flexible suctioning ureteral access sheath combined with flexible ureteroscope to treat unilateral renal calculi. World J Urol. 2023 Dec;41(12):3619-3627. doi: 10.1007/s00345-023-04648-w. Epub 2023 Oct 11.
PubMed 37821778Nao T, Iga R, Yoshimura R, Kurano Y, Yamamoto S, Tamura K. A new method for effective use of the ClearPetra ureteral access sheath for a giant ureteral stone. Urol Case Rep. 2023 Oct 23;51:102599. doi: 10.1016/j.eucr.2023.102599. eCollection 2023 Nov.
PubMed 38024505Gauhar V, Traxer O, Castellani D, Sietz C, Chew BH, Fong KY, Hamri SB, Gokce MI, Gadzhiev N, Galosi AB, Yuen SKK, El Hajj A, Ko R, Zawadzki M, Sridharan V, Lakmichi MA, Corrales M, Malkhasyan V, Ragoori D, Soebhali B, Tan K, Chai CA, Tursunkulov AN, Tanidir Y, Persaud S, Elshazly M, Kamal W, Tefik T, Shrestha A, Tiong HC, Somani BK. Could Use of a Flexible and Navigable Suction Ureteral Access Sheath Be a Potential Game-changer in Retrograde Intrarenal Surgery? Outcomes at 30 Days from a Large, Prospective, Multicenter, Real-world Study by the European Association of Urology Urolithiasis Section. Eur Urol Focus. 2024 Dec;10(6):975-982. doi: 10.1016/j.euf.2024.05.010. Epub 2024 May 24.
PubMed 38789313